CS100 Accessory Kit, Italian, 220 V
Catalogue number 0020-00-0463-07, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
64510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Datascope Corp, United States |
|---|---|
| FDA product code | DSP |
| Device type | System, Balloon, Intra-Aortic And Control |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3535 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K031636 |
| Record published | 2016-09-20 |
| Record revised | 2023-02-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Distribution end date | 2016-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0020-00-0463-07 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 224 |
| Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB | Datascope Corp | 10 |
| CS300 Intra-Aortic Balloon Pump, Refurbished, English,non-Uts,dom | Datascope Corp | 4 |
| CS100 Intra-Aortic Balloon Pump, Refurbished, English,uts,dom | Datascope Corp | 3 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 3 |
| CS300 Intra-Aortic Balloon Pump, Refurbished, Spanish,uts,intl | Datascope Corp | 3 |
| Ultra Iabp Catheter Kit | Insightra Medical, Inc. | 3 |
| Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the Sensation Plus 7 | Datascope Corp | 2 |
| CS100 Intra-Aortic Balloon Pump, Refurbished, Portuguese,non-Uts,intl | Datascope Corp | 2 |
| CS300 Intra-Aortic Balloon Pump, Refurbished, FRENCH,NON-UTS,110V | Datascope Corp | 2 |
| Yamato Plus-R 30cc IAB With Accessories AND Retraction KIT | Datascope Corp | 2 |
| CS100 Intra-Aortic Balloon Pump, Refurbished, Spanish,non-Uts,intl | Datascope Corp | 2 |
Showing 12 of 268. All products under System, Balloon, Intra-Aortic And Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181122 | 2018-05-31 |
| K172305 | 2017-10-12 |
| K163542 | 2017-01-31 |
| K151254 | 2015-07-02 |
| K133074 | 2013-12-12 |
| K063525 | 2007-01-05 |
| K041281 | 2004-06-07 |
| K031636 | 2003-08-11 |
| K031569 | 2003-06-10 |
| K020257 | 2002-04-24 |
| K013326 | 2001-11-02 |
| K003598 | 2000-12-21 |
| K002949 | 2000-10-20 |
| K994157 | 2000-03-13 |
| K980780 | 1998-05-29 |
| K980385 | 1998-05-01 |
| K965236 | 1997-07-01 |
| K964987 | 1997-03-17 |
| K961509 | 1996-11-15 |
| K960166 | 1996-04-24 |
| K942454 | 1995-02-24 |
| K944460 | 1994-12-09 |
| K940231 | 1994-09-13 |
| K940178 | 1994-08-09 |
| K911000 | 1993-08-25 |
| K914802 | 1993-08-25 |
| K920427 | 1993-08-03 |
| K905663 | 1993-08-02 |
| K922235 | 1993-04-27 |
| K921638 | 1993-02-10 |
| K913847 | 1992-03-11 |
| K912629 | 1992-03-11 |
| K910997 | 1991-11-05 |
| K905056 | 1991-06-11 |
| K903930 | 1990-11-16 |
| K904414 | 1990-10-22 |
| K904018 | 1990-10-19 |
| K903769 | 1990-10-19 |
| K903867 | 1990-10-19 |
| K903893 | 1990-10-19 |
| K903892 | 1990-10-19 |
| K903736 | 1990-10-09 |
| K902057 | 1990-09-25 |
| K896497 | 1990-08-17 |
| K896430 | 1990-02-05 |
| K893243 | 1989-06-20 |
| K880289 | 1988-06-10 |
| K863219 | 1987-01-14 |
| K850482 | 1985-08-22 |
| K833828 | 1985-02-08 |
| K831235 | 1985-02-08 |
| K831397 | 1983-11-02 |
| K831307 | 1983-11-02 |
| K823342 | 1983-01-24 |
| K821951 | 1982-12-21 |
| K820882 | 1982-10-18 |
| K821065 | 1982-08-19 |
| K813182 | 1982-03-31 |
| K811372 | 1981-08-03 |
| K810297 | 1981-05-06 |
| K802167 | 1981-01-13 |
| K801601 | 1981-01-13 |
| K790775 | 1979-10-01 |
| K780280 | 1978-03-15 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Datascope Corp | 510(k) number | 2026-01-23 | Class II | Under Investigation by firm | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. | 10,897 units | |
| Datascope Corp | 510(k) number | 2017-07-17 | Class I | Under Investigation by firm | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. | 14,547 units (5,049 domestically & 9,498 units international | |
| Datascope Corp | 510(k) number | 2017-07-17 | Class I | Under Investigation by firm | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. | 14,547 units (5,049 domestically & 9,498 units international | |
| Datascope Corp | 510(k) number | 2017-06-16 | Class I | Component design/selection | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. | 12,319 units total | 2019-11-29 |
| Datascope Corp | 510(k) number | 2017-06-16 | Class I | Component design/selection | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. | 12,319 units total | 2019-11-29 |
| Datascope Corp | 510(k) number | 2014-03-21 | Class I | Nonconforming Material/Component | Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. | 11,881 units (US 5183 and OUS 6698) | 2018-03-20 |
| Datascope Corp | 510(k) number | 2010-05-10 | Not classified | Other | Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to vie | 161 total devices | 2010-10-27 |
Recalls
16 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-02-06 | Class III | Under Investigation by firm | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay | 28 units (20 US, 8 OUS) |
| 2026-01-23 | Class II | Under Investigation by firm | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. | 10,897 units |
| 2025-11-04 | Class II | Component design/selection | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. | 11,470 units |
| 2025-11-04 | Class II | Component design/selection | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. | 47 units |
| 2025-10-23 | Class III | Process change control | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | 47 units (44 US, 3 OUS) |
| 2025-10-23 | Class III | Process change control | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | 11470 units (5095 US, 6375 OUS) |
| 2024-09-17 | Class II | Error in labeling | There is discrepant labeling on the inner and outer packaging of the device. | 160 units |
| 2024-08-08 | Class I | Software design | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-A | 5,475 units |
| 2024-08-08 | Class I | Software design | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Int | 5,475 units |
| 2024-08-08 | Class I | Software design | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-A | 5,475 units |
| 2024-08-08 | Class I | Software design | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Int | 5,475 units |
| 2023-07-31 | Class II | Under Investigation by firm | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. | 9379 units |
| 2023-07-31 | Class II | Under Investigation by firm | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. | 9379 units |
| 2023-07-31 | Class I | Device Design | Users reported “System Over Temperature” alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. | 11574 units (5413 US, 6161 OUS) |
| 2023-07-31 | Class I | Under Investigation by firm | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the | 9175 units |
| 2023-07-31 | Class I | Under Investigation by firm | Users were identifying autofill failure conditions on the devices causing pump stops. | 9175 units |
| 2023-07-31 | Class I | Under Investigation by firm | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the | 9175 units |
| 2023-07-31 | Class I | Under Investigation by firm | Users were reporting instances of “Gas Loss in IAB Circuit” and “Gas Gain in IAB Circuit” alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not | 9175 units |
| 2023-07-31 | Class I | Under Investigation by firm | Users were reporting instances of “Gas Loss in IAB Circuit” and “Gas Gain in IAB Circuit” alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not | 9175 units |
| 2023-07-31 | Class I | Under Investigation by firm | Users were identifying autofill failure conditions on the devices causing pump stops. | 9175 units |
| 2023-07-31 | Class I | Device Design | Users reported “System Over Temperature” alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. | 47 units (42 US, 5 OUS) |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-23 | Class II | Under Investigation by firm | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; su | 321,609 total kits |
| 2023-06-05 | Class I | Device Design | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC | 9174 (4586 US; 4588 OUS) |
| 2023-06-05 | Class I | Device Design | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC | 9174 (4586 US; 4588 OUS) |
| 2023-06-05 | Class I | Component design/selection | An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy. | 9174 (4586 US; 4588 OUS) in total |
| 2023-06-05 | Class I | Component design/selection | An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy. | 9174 (4586 US; 4588 OUS) in total |
| 2023-05-04 | Class III | Under Investigation by firm | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. | 4 units |
| 2023-04-04 | Class II | Component design/selection | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle. | 54 units |
| 2023-02-28 | Class II | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB i | 391 total IABPs |
| 2023-02-28 | Class II | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB i | 391 total IABPs |
| 2023-02-28 | Class II | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB i | 669 safety disks |
| 2023-02-28 | Class II | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB i | 10 |
Source: U.S. FDA establishment registration and device listing records, public domain.
Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.